T-20 in HIV Patients With Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs

HIV Infections Clinical Trial

Official title:

A Phase III Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20 (HIV-1 Fusion Inhibitor) in Combination With an Optimized Background Regimen, Versus Optimized Background Regimen Alone, in Patients With Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021554
• Other study ID #: 295D
• Secondary ID: T20-302
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2001
• Last updated: June 23, 2005

Study information

• Verified date: May 2002
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to show if a dose of T-20 added to an anti-HIV combination (chosen specifically for each patient) lowers viral load by at least a certain level after 24 weeks as compared to an anti-HIV combination (chosen specifically for each patient) alone. Another purpose is to show if the patient response to T-20 will be maintained for 48 weeks.

Description:

An OB regimen is selected to be initiated at baseline by the physician and patient. The OB regimen is based on the patient's prior treatment history as well as the results from the first screening visit HIV-1 genotypic and phenotypic (GT and PT) resistance testing and prior GT/PT antiretroviral resistance testing (if available). Prior or current laboratory abnormalities, including triglycerides and cholesterol, should also be taken into account when selecting the OB regimen. Patients are stratified with respect to the following: 1) screening viral load (less than 40,000 or 40,000 or more copies/ml); and 2) number of allowed investigational antiretrovirals (0, 1, or 2). Patients then are randomized to receive 1 of the following treatments for 48 weeks: OB regimen or OB plus T-20 regimen. Patients are seen for evaluation of efficacy and safety at Weeks 1, 2, and 4, every 4 weeks through Week 24, and then every 8 weeks through Week 48. In addition, efficacy only is evaluated at Weeks 6, 10, and 14. Patients also may be seen at additional visits during the study for plasma HIV-1 RNA measurements to potentially confirm virological failure.

Patients initially randomized to the OB arm who meet the criteria for virological failure and who switch to OB plus T-20 after Week 8 are followed under a new ("switch") schedule of assessments. Patients are encouraged to change their OB regimen at the time of switch.

Patients initially randomized to the OB plus T-20 arm who meet the criteria for virological failure may continue to receive OB plus T-20 if the patient and the physician feel that there is sufficient benefit. Patients are encouraged to change their OB regimen after Week 8 if they choose to continue on OB plus T-20 despite meeting the criteria for virological failure.

Patients on OB or OB plus T-20 arm who meet the criteria for virological failure but who do not wish to either switch to T-20 (for patients initially randomized to OB arm) or continue with T-20 (for patients initially randomized to OB plus T-20) are allowed to remain in the study for a maximum of 1 month.

At the end of the 48 weeks of treatment, patients are allowed to participate in 1 of the following treatment extensions: a) roll-over and receive OB plus T-20 (for patients receiving OB alone); or b) continue taking OB plus T-20 (for patients already receiving OB plus T-20), for a maximum of an additional 48 weeks (plus 4 weeks safety follow-up period), or until 12 weeks after commercial availability of T-20 in the country in which they are treated, whichever comes first. All patients are followed for a maximum of 100 weeks from their initial baseline visit date.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV infected.

• Are at least 16 years of age.

• Have an HIV-1 RNA of at least 5,000 copies/ml.

• Have received anti-HIV drugs for at least 3 months and/or have written records of resistance to at least 1 member of each of the 3 classes of anti-HIV drugs (nucleoside reverse transcriptase inhibitors [NRTIs], nonnucleoside reverse transcriptase inhibitors [NNRTIs], and protease inhibitors [PIs]). Resistance to NNRTIs may not be required in certain cases.

Study Design

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Enfuvirtide

Locations

Country	Name	City	State
Australia	Carlton Clinic	Carlton
Australia	Holdsworth House General Practice	Darlinghurst
Australia	Saint Vincent's Hosp	Darlinghurst
Australia	Royal Brisbane Hosp	Herston
Australia	Alfred Hosp	Prahan
Australia	Prahran Market Clinic	South Yarra
Australia	Taylors Square Clinic	Sydney
Belgium	Inst of Tropical Medicine	Antwerpe
Belgium	CHU Saint Pierre	Brussels
Belgium	UZ Gasthuisberg	Leuven
Germany	Rheinische Friedrich Wilhelms Universitaet Medizinische	Bonn
Germany	Klinikum Der Johann Wolfgang Goethe Universitat	Frankfurt
Germany	Allgemeines Krankenhaus St Georg	Hamburg
Germany	Universitatskrankenhaus Eppendorf	Hamburg
Italy	UO Malattie Infettive	Firenze
Italy	Clinica Malattie Infettive	Milano
Italy	Ospedale Amedeo di Savoia	Torino
Netherlands	Natac Med Centre	Amsterdam
Netherlands	Univ Medical Center Utrecht	CX Utrecht
Spain	Hospital Germans Trias I Pujol	Barcelona
Spain	Hosp La Paz	Madrid
Spain	Hospital General Universitario	Valencia
Sweden	University Hospital Mas	Malmoe
Sweden	Karolinska Hospital	Stockholm
Sweden	Venhalsan Soder Hosp	Stockholm
Switzerland	Univ Hosp Basel / Med Outpatient Dept	Basel
Switzerland	Hopital cantonal / Div des maladies infectieuses	Geneve
Switzerland	CHUV	Lausanne
Switzerland	Universitatsspital Zurich	Zurich
United Kingdom	Brighton Gen Hosp	Brighton
United Kingdom	Western Gen Hosp	Edinburgh
United Kingdom	Royal Liverpool Univ Hosp	Liverpool
United Kingdom	Chelsea and Westminster Hosp	London
United Kingdom	King's College Hospital	London
United Kingdom	Royal Free Hosp	London
United Kingdom	Univ College London Med School	London
United Kingdom	North Manchester Gen Hosp	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Trimeris

Countries where clinical trial is conducted

Australia,  Belgium,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

Lazzarin A, Clotet B, Cooper D, Reynes J, Arastéh K, Nelson M, Katlama C, Stellbrink HJ, Delfraissy JF, Lange J, Huson L, DeMasi R, Wat C, Delehanty J, Drobnes C, Salgo M; TORO 2 Study Group. Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. N Engl J Med. 2003 May 29;348(22):2186-95. — View Citation